Status:
COMPLETED
Pharmacometabolomic of Trabectedin in Soft Tissue Patients
Lead Sponsor:
Centro di Riferimento Oncologico - Aviano
Conditions:
Sarcoma
Eligibility:
All Genders
18+ years
Brief Summary
This perspective, mono institutional study is addressed to find potential serum and urine biomarkers predictive of the pharmacokinetic and pharmacodynamic profile of soft tissue sarcomas patients trea...
Detailed Description
This investigation enrolled patients with unresectable and/or metastatic soft tissue sarcoma not responsive to the first-line treatment based on anthracycline/ifosfamide. Patients underwent trabectedi...
Eligibility Criteria
Inclusion
- Advanced Soft Tissues Sarcoma STSs (unresectable and/or metastatic disease).
- One previous systemic treatment with ananthracycline ± ifosfamide.
- Measurable disease, as defined by RECIST criteria.
- ECOG PS ≤2.
- Age ≥18 years.
- A minimum of 3 weeks since prior tumor directed therapy
- Recovery from toxic effects of prior therapies to NCI CTC Grade 1 or lower.
- Adequate haematological, renal liver function.
- Ability and willingness to provide informed consent
Exclusion
- Pregnant or breast-feeding women
- Prior exposure to Trabectedin.
- Peripheral neuropathy, Grade 2 or higher.
- Known CNS metastases.
- Active viral hepatitis or chronic liver disease.
- Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within one year before enrolment, uncontrolled arterial hypertension or arrhythmias.
- Active major infection.
- Other serious concomitant illnesses.
Key Trial Info
Start Date :
April 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2020
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04394728
Start Date
April 1 2015
End Date
January 1 2020
Last Update
May 19 2020
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